LS - Pharma-Consultant
Wipro Limited
Kolkata
2d ago
source : Shine

Responsibilities : Understanding of clinical documents (Safety , Submission and R& D related documents) Set up, implement and maintain an eTMF (Trial Master File) in accordance with the DIA reference model Oversight of compliance alongside quality functions and data privacy requirements Ensure the completeness of the Trial Master File (TMF) for assigned clinical studies Identification and categorizing of clinical trial documents Quality checking of documents for legibility, duplicity and completeness Identification of various properties and features of clinical documents Provide support to Clinical Document QC Specialist with regards to ICH / GCP documentationWorking Experience / Skill set in : Clinical document management system Clinical research monitoring, pharmaceutical, CRO or healthcare industry Knowledge of ICH GCP, 21 CFR part11 Working knowledge of clinical essential documents, including trial master file Relevant clinical research experience in industry or in clinical practice as a trial / study coordinator

Mandatory Skills : LS - Pharma-L3 Consulting-L2

Desirable Skills :

Language Skills : English Language-L2

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